A Phase 4 interventional study of Plerixafor in Autologous Stem Cell Transplantation, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2013-12-10.
Sponsored by Tel-Aviv Sourasky Medical Center · Phase 4, Interventional, and Treatment
Plerixafor has been intensively used in recent years for harvesting autologous stem cells from lymphoma and myeloma adult patients. Its use is indicated after failure to harvest with GCSF alone. Nevertheless, in the pediatric population its appliance is less well established and the indications are less well confirmed .Several disease states and diagnoses may prompt the anticipation of difficulties in harvesting stem cells using GCSF only. Such patients may benefit utilizing plerixafor in first-line rather than exhausting the stem cell niche with GCSF alone and only than go for plerixafor as second-line rescue procedure.
In this study we propose to examine the applicability and feasibility of harvesting autologous stem cells by means of GCSF + plerixafor in first-line measure for pediatric patients with specific indications.
Improve and report outcomes of children undergoing peripheral stem and progenitor cell harvesting applying plerixafor in first-line aphaeresis, including:
Pre-harvesting FACS-derived CD34+ cell number. Number of stem cells harvested. Number of T-cells harvested. Days of hospitalization.
Procedure related toxicity including:
Infections. Line complications. Other organ toxicities.
Compare outcomes of plerixafor-derived stem and progenitor cells harvesting between different pediatric oncological diseases, including high-risk neuroblastoma, high-risk brain tumors, high-risk sarcomas and relapsed lymphomas.
Outcomes to be analyzed:
Morbidity:
Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.
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Patients with high-risk neuroblastoma after third-line chemotherapy. Patients with high-risk medulloblastoma/PNET after spinal irradiation. Patients with primary sarcomas after third or more line therapies, Patients with relapsed lymphomas after third line chemotherapy. Patients with relapsed neuroblastoma, medulloblastoma, lymphoma or sarcoma after previous autologous stem cell transplantation.
Age equal to or less than 30 years at time of diagnosis. Patients eligible for AHCT according to their treating protocol or patients with neuroblastoma eligible for 131I-MIBG-therapy.
Patients with maligancies disease who candidates to autologous stem cell transplantation ,taking from them autologus stem cell as back up.
Exclusion Criteria:
Healthy stem cells donors
Patients who older than 30 years
Patients with non maligancies disease that candidates to autologous stem cell transplantation
The use of plerixafor as additive measurment for the conventional stem cell collection protocol.
Drug: Plerixafor
Peripheral blood stem cell content by means of percentage of CD34+ cells
1. Peripheral blood stem cell content before harvesting by means of percentage of CD34+ cells, after conditioning protocol (4 days of 10mcg/kg GCSF per day) and after adding one dose of plerixafor 0.24mg/kg 10 hours before collection. 2. Number of CD34+ stem cells that were collected after adding plerixafor with relation to the target number of stem cells needed.
Time frame: After conditioning protocol (4 days of 10mcg/kg GCSF per day), and on the fifth day after one dose of plerixafor 0.24mg/kg, 10 hours before collection - before harvesting. After harvesting - the number of collected CD34+ cells.
No study locations are listed for this record.
This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Tel-Aviv Sourasky Medical Center